Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia

Technology
Arm/hand function
Online since 28 August 2023, updated 232 days ago

About this trial

This trial is enrolling individuals with chronic, incomplete, cervical spinal cord injuries to test the effect of a home-based, telehealth-supported intervention combining Blood Flow Restriction Enhanced Neuromuscular Electrical Stimulation (BES) Exercise and Transspinal Stimulation (TS) on arm and hand function. TS is a technique for stimulating the spinal cord via surface electrodes to modify spinal cord function. Participants will first undergo baseline measurements at the laboratory for 2 weeks. Then they will undergo 2 weeks of training at home to become familiar with the telehealth platform. Participants will then undergo 3 sessions/week for 16 weeks of either: 1) BES + active TS; or 2) BES + sham (inactive) TS at home with telehealth supervision. Final testing will be performed after 30 weeks.

Included participants

Gender
All
Age
18 - 70 years
Injury level
C1 - C8
  • Severity (AIS)?
  • AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 1 year
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-C8
    Additionally, participants must
    Have visible muscle contraction in response to neuromuscular electrical stimulation of the wrist extensor muscles
    Have a companion that can assist the participant with research activities throughout the study
    Possess appropriate technology to enable telehealth participation in the trial (web camera, computer, microphone, speakers, high-speed broadband internet connection, telephone number)

    What’s involved

    Type

    Technology

    Details

    1) Participants will undergo baseline measurements at the laboratory for 4 weeks 2) Participants will undergo 2 educational sessions/week to familiarize with the TS and telehealth platform at home 3) Participants will then undergo 16 weeks of 3 sessions/week of either i) BES + active TS or ii) BES + sham TS at home with telehealth supervision 4) Final testing will be performed 20 weeks after baseline testing--total length of participation is 30 weeks

    Potential benefits

    Main benefits

    Arm/hand function

    Additional benefits

    General health

    Sensory function

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 15 Jun 2022
    • Organisation
    • Virginia Commonwealth University
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 15 Jun 2022
    • Organisation
    • Virginia Commonwealth University

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more